The purpose of the company’s clinical development program is to support the ongoing market introduction of the Ozilia™ Migraine technology for chronic migraine in the EU and lay the foundation for regulatory market access in other markets such as the USA.
Our clinical development strategy is aimed to conduct studies of specific nature and shorter duration ourselves, and to encourage and facilitate other independent external investigator-initiated studies once such opportunities arise.
Ongoing & Planned Clinical Studies
The effect of Chordate’s treatment has been investigated in a number of studies over the years, where Chordate has often been the sponsor. These studies have been published in the articles below.
Hoffmann J et al, Kinetic Oscillation Stimulation for the preventive treatment of chronic migraine: results from a randomized- controlled trial. Headache: The Journal of Head and Face Pain: First published: 14 June 2023, https://doi.org/10.1111/head.14523 page 143-144
Tie-Qiang Li, Yanlu Wang, Rolf Hallin, Jan-Erik Juto. Resting-state fMRI study of acute migraine treatment with kinetic oscillation stimulation in nasal cavity. Neurolmage: Clinical 2016; 451-459
Jan-Erik Juto, MSc, MD, PhD; Rolf G. Hallin, MD, PhD. Kinetic Oscillation Stimulation as Treatment of Acute Migraine: A Randomized, Controlled Pilot Study. Wiley Periodicals, Inc. 2014
Lino Di Rienzo Businco, Marco Radici, Pasquale Longo, Fausto Carru, Andrea Di Rienzo Businco (2023) Effectiveness of Kinetic Oscillation Stimulation Treatment in Persistent Moderate-severe Allergic Rhinitis Compared to Medical Therapy. Journal of Otolaryngology Research & Reports. 2023(2)112
Monti G, Seccia V, Berrettini S, Picariello M, Gramellini G, et al. (2022) Clinical Results of Kinetic Oscillation Stimulation (Ozilia™ Migraine.) in Non-Allergic Rhinitis. J Clin Res Med Volume 5(3): 1–4. DOI: 10.31038/JCRM.2022532
Fokkens et al. The Effect Of Kinetic Oscillation Stimulation On Symptoms Of Non-Allergic Rhinitis: A Per-Protocol Analysis Of A Randomized Controlled Trial. Journal of Otolaryngology Head & Neck Surgery, May 15, 2020 DOI:10.24966/OHNS-010X/100042
Fokkens et al. Rhinology Future Debates 2017 by EUFOREA: Novel treatments and surgical solutions in rhinology. Clinical Otolaryngology. 2018;1–10.
Ehnhage, A, Sahlstrand Johnsson P, et al Treatment of idiopathic rhinitis with kinetic oscillations – a multi- centre randomized controlled study. Acta Oto-laryngologica, 2016; 136(8):852-859
Juto JE, Axelsson M. Kinetic oscillation stimulation as treatment of non-allergic rhinitis: an RCT study. Acta Otolaryngol 2014; 134:506-12.
Markus Jerling MD, Iwona Cygankiewicz, Nabil Al-Tawil, Borje Darpo, Anders Ljungström, Wojciech Zareba. Effects of intranasal kinetic oscillation stimulation on heart rate Variability. Ann Noninvasive Electrocardiol. 2017;e12474.
Tie-Qiang Li, Yanlu Wang, Rolf Hallin, Jan-Erik Juto. Resting-state fMRI study of acute migraine treatment with kinetic oscillation stimulation in nasal cavity. NeuroImage: Clinical 12 (2016) 451–459
Sarin S. The role of the nervous system in rhinitis. J Allergy Clin Immunol 2006; 118:999-1016.
Safwan S. Jaradeh, MD; Timothy L. Smith, MD, MPH; Laura Torrico, MD; Thomas E. Prieto, PhD; Todd A. Loehrl, MD; Ronald J. Darling, MD; Robert J. Toohill, MD, FACS. Autonomic Nervous System Evaluation of Patients With Vasomotor Rhinitis. Laryngoscope 2000; 110:1828–1831
Hellings P.W., Klimek L., Cingi C., Agache I., Akdis C., Bachert C., Bousquet J., Demoly P., Gevaert P., Hox V., Hupin C., Kalogjera L., Manole F., Mösges R., Mullol J., Muluk N.B., Muraro A. , Papadopoulos N., Pawankar R. , Rondon C. , Rundenko M., Seys S.F., Toskala E., Van Gerven L., Zhang L., Zhang N., Fokkens W.J. Non-Allergic Rhinitis: Position paper of the European Academy of Allergology and Clinical Immunology. Allergy. 2017
K. Scadding, H. H. Kariyawasam, G. Scadding, R. Mirakian, R. J. Buckley, T. Dixon, S. R. Durham, S. Farooque, N. Jones, S. Leech, S. M. Nasser, R. Powell, G. Roberts, G. Rotiroti, A. Simpson, H. Smith, A. T. Clark, BSACI guideline for the diagnosis and management of allergic and non-allergic rhinitis (Revised Edition 2017; First edition 2007), Clin Exp Allergy. 2017;47:856–889.
Pete Smith, David Price, Richard Harvey, Andrew Simon Carney, Vicky Kritikos, Sinthia Z Bosnic-Anticevich, Louise Christian, Derek Skinner, Victoria Carter, Alice Marie Sybille Durieux. Medication-related costs of rhinitis in Australia: a NostraData cross sectional study of pharmacy purchases. Journal of Asthma and Allergy. 2017:10 153–161
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